81 FR 55 pg. 15173 - Milton W. Chu, M.D.; Filing of Color Additive Petition
Type: PRORULEVolume: 81Number: 55Page: 15173
Page: 15173Docket number: [Docket No. FDA-2016-F-0821]
FR document: [FR Doc. 2016-06397 Filed 3-21-16; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 73 and 74
[Docket No. FDA-2016-F-0821]
Milton W. Chu, M.D.; Filing of Color Additive Petition
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of petition.
SUMMARY:
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Milton W. Chu, M.D., proposing that the color additive regulations be amended to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.
DATES:
The color additive petition was filed on February 19, 2016.
FOR FURTHER INFORMATION CONTACT:
Laura Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1275.
SUPPLEMENTARY INFORMATION:
Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 6C0305), submitted by Milton W. Chu, M.D., 5800 Santa Rosa Rd., Suite 111, Camarillo, CA 93012. The petition proposes to amend the color additive regulations in §?73.3126 Titanium dioxide (21 CFR 73.3126) and §?74.3045 [Phthalocyaninato (2-)] copper (21 CFR 74.3045) to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.
We have determined under 21 CFR 25.32(l) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Dated: March 17, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.
[FR Doc. 2016-06397 Filed 3-21-16; 8:45 am]
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